[Federal Register Volume 71, Number 242 (Monday, December 18, 2006)]
[Notices]
[Pages 75762-75764]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-21486]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0036]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Experimental Study of 
Possible Footnotes and Cueing Schemes to Help Consumers Interpret 
Quantitative Trans Fat Disclosure on the Nutrition Facts Panel

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
December 18, 2006.

ADDRESSES:  To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Experimental Study of Possible Footnotes and Cueing Schemes to Help 
Consumers Interpret Quantitative Trans Fat Disclosure on the Nutrition 
Facts Panel--(OMB Control Number 0910-0532--Reinstatement)

    FDA is requesting OMB approval of an experimental study of possible 
footnotes and cueing schemes intended to help consumers interpret 
quantitative trans fat information on the Nutrition Facts Panel (NFP) 
of a food product. The purpose of the experimental study is to help 
FDA's Center for Food Safety and Applied Nutrition formulate decisions 
and policies affecting labeling requirements for trans fat disclosure.
    In the Federal Register of July 11, 2003 (68 FR 41434), FDA issued 
a final rule requiring disclosure on the Nutrition Facts Panel of 
quantitative trans fat information on a separate line without any 
accompanying footnote. At the same time, the agency issued an advance 
notice of proposed rulemaking entitled ``Food Labeling: Trans Fatty 
Acids in Nutrition Labeling; Consumer Research to Consider Nutrient 
Content and Health Claims and Possible Footnote or Disclosure 
Statements'' (68 FR 41507) which requested comments about possible 
footnotes to help consumers better understand trans fat declarations on 
the product label. The agency sought comments about whether it should 
consider requiring statements about trans fat, either alone or in 
combination with saturated fat and cholesterol, as a footnote on the 
Nutrition Facts Panel to enhance consumers' understanding about such 
cholesterol-raising lipids and how to use information on the label to 
make healthy food choices. Comments received in response to the notice 
contained suggested footnotes and cueing schemes. The proposed 
experimental study will evaluate the ability of several possible 
footnotes and cueing schemes to help consumers make heart-healthy food 
choices. The results of the experimental study will provide empirical 
support for possible policy decisions about the need for such 
requirements and the appropriate form they should take.
    FDA or its contractor will use information gathered from Internet 
panel samples to evaluate how consumers understand and respond to 
possible footnote and cueing schemes. The distinctive features of 
Internet panels for the purpose of the experimental study are that they 
allow for controlled visual presentation of study materials, 
experimental manipulation of study materials, and the random assignment 
of subjects to condition. Experimental manipulation of labels and 
random assignment to condition makes it possible to estimate the 
effects of the various possible footnotes and cueing schemes while 
controlling for individual differences between subjects. Random 
assignment ensures that mean differences between conditions can be 
tested using well-known techniques such as analysis of variance or 
regression analysis to yield statistically valid estimates of effect 
size. The study will be conducted using a convenience sample drawn from 
a large, national consumer panel of about one million households.
    Participants will be adults, age 18 and older, who are recruited 
for a study about foods and food labels. Each participant will be 
randomly assigned to 1 of the 54 experimental conditions derived from 
fully crossing 8 possible footnotes/cueing schemes, 3 product types, 
and 2 prior knowledge conditions.
    FDA will use the information from the experimental study to 
evaluate regulatory and policy options. The agency often lacks 
empirical data about how consumers understand and respond to statements 
they might see in product labeling. The information gathered from this 
experimental study will be used to estimate consumer comprehension and 
the behavioral impact of various footnotes and cueing schemes intended 
to help consumers better understand quantitative trans fat information.
    The experimental study data will be collected using participants of 
an Internet panel of approximately one million people. Participation in 
the experimental study is voluntary.
    In the Federal Register of February 6, 2006 (71 FR 6079), FDA 
published a 60-day notice requesting public comment on the information 
collection that will take place as part of the experimental study. FDA 
received two letters in response to the notice, each containing 
multiple comments.

[[Page 75763]]

    (Comment 1) One comment stated that the organization concurs with 
the objectives of the study and believes the information from this 
study will be useful to FDA in developing labeling policy to assist 
consumers with interpretation of trans fat claims in food labeling. 
Another comment expressed concern that the NFP of only one of the three 
product pairs (margarine) showed polyunsaturated fat and 
monounsaturated fat content and recommended that the NFPs for all three 
products tested in the study show the fuller fat profile.
    (Response) FDA disagrees with the recommendation that the NFPs for 
all three products tested in the study disclose a fuller fat profile. 
Most NFPs do not include the optional polyunsaturated fat and 
monounsaturated fat content. Typically, this information is disclosed 
on NFPs for products that are entirely or largely composed of fat 
(e.g., butter, margarine, and cooking oils). In these cases, the fat 
profile may be shown in greater detail because consumers may use this 
information to select among alternative food products. The NFPs for the 
product pairs tested in the study are consistent with actual donut, 
margarine, and frozen lasagna labels. Because the recommended change 
would limit products tested in the study to those such as butter, 
margarine and cooking oils, FDA will retain the NFPs as proposed.
    (Comment 2) One comment suggested that the NFPs should not reflect 
rounding, to minimize potential consumer confusion. The comment 
specifically recommended that FDA edit the study NFPs containing 
declarations of polyunsaturated and monounsaturated fats (i.e., for the 
margarine product pair) to declare total fat grams in an amount equal 
to the sum of the four listed fatty acids.
    (Response) FDA agrees that for the margarine labels, which include 
the four fatty acids under total fat, the fatty acids gram (g) amounts 
declared should add up to the total fat gram amount to avoid raising 
questions or distracting the participants in the margarine conditions. 
We made the requested change.
    (Comment 3) One comment suggested that, for the margarine labels, 
FDA should edit the polyunsaturated and monounsaturated values to be as 
equal as possible in the product pairings to ensure that the focus is 
on the saturated fat and trans fat content.
    (Response) FDA disagrees with the suggested change to the NFPs for 
the margarine product pairs. In order to keep the values for the 
polyunsaturated and monounsaturated fats identical in the margarine 
pairs, the saturated fat content would become unrealistically high in 
one label because it is the only fat component that could increase when 
trans fat equals zero. FDA will retain the NFPs as proposed.
    (Comment 4) One comment noted that only one of the NFPs for the 
three products tested in the study showed some cholesterol present in 
the product; the other two products disclosed cholesterol as zero. In 
particular, the comment identified lasagna as unlikely to contain 0 
milligrams of cholesterol.
    (Response) FDA agrees that zero cholesterol is not likely to be a 
realistic amount of cholesterol disclosed on a NFP for a lasagna 
product and has revised the NFPs for the lasagna pairs. In addition, 
FDA changed a product category from cookies to donuts and edited the 
NFPs for the new donut product pair to add a disclosure of cholesterol.
    (Comment 5) One comment critiqued the draft Full Information 
treatment language. The comment criticized the one-page summary 
because: (1) It did not identify calories in the discussion of fat as a 
major source of energy and (2) it did not relate the calorie 
contribution of fat to that of carbohydrates and protein. The comment 
also criticized the information about sources of trans fat because it 
omitted mention of natural sources of trans fat in the diet, which the 
comment suggested would help ensure factually correct and balanced 
information about sources of trans in the diet. The comment questioned 
the value of stating that trans fat extends shelflife and has desirable 
taste characteristics since many saturated fat sources are relatively 
shelf stable and have desirable taste characteristics.
    (Response) FDA agrees and has revised the Full Information 
treatment in response to these concerns. Calories and other sources of 
energy are now mentioned in the introductory passage. Natural sources 
of trans fat are now mentioned and the similarity between trans fat and 
saturated fat in terms of shelflife and taste are now addressed. The 
revised draft will be included in the study pretest and further 
revisions will be made if FDA determines they are needed based upon 
pretest results.
    (Comment 6) One comment suggested consumer confusion may be caused 
when a NFP for a product discloses 0 g of trans fat but the ingredient 
list discloses an ingredient that contains trans fat, as is permitted 
by the trans fat labeling regulations. The comment concluded that FDA 
should add experimental conditions in which this occurs. The comment 
suggested that for this situation the study should test language for a 
footnote to the ingredient list to explain that there may be a trans 
fat ingredient in the product when the NFP shows trans fat as zero.
    (Response) FDA disagrees with the proposed addition to the study's 
experimental conditions. Under existing trans fat labeling regulations, 
food manufacturers are allowed to list amounts of trans fat less than 
0.5 g per serving as zero on the NFP. While such situations occur in 
the marketplace and are permitted by the trans fat labeling 
regulations, whether this causes consumer confusion is an issue outside 
the scope of the proposed research, which focuses on the effects of NFP 
footnotes and alternative presentations of trans fat information in the 
NFP on consumers' ability to correctly identify more healthful food 
products. The Office of Nutritional Products, Labeling and Dietary 
Supplements has received and responded to a separate letter on this 
topic from the commenter.

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                         No. of        Annual Frequency     Total Annual        Hours per
     Activity         Respondents        per Response        Responses           Response         Total Hours
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Pretest                           40                  1                 40                .25                 10
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Study                          3,240                  1              3,240                .25                810
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Total              .................  .................  .................  .................                820
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.



[[Page 75764]]

    Dated: December 8, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-21486 Filed 12-15-06; 8:45 am]
BILLING CODE 4160-01-S